# K163217: GORE BIO-A Tissue Reinforcement

- Pathway: 510(k) (Traditional)
- Applicant: W. L. Gore & Associates, Inc.
- Decided: Feb 10, 2017 after 86 days
- Product code: OXF (Mesh, Surgical, Absorbable, Plastic And Reconstructive Surgery)
- Device class: 2
- Regulation: 21 CFR 878.3300
- Recalls of this device: none
- Data: FDA decisions to Oct 25, 2026; recalls to Oct 12, 2026

## Lineage
Longest line of descent: 8 generations back to K921895 (1992). 52 ancestors in all.
5 later devices descend from it; 3 cite it directly.
0 of 58 devices in its family (counting itself) have a Class I recall.

## Predicates on the family tree (from the FDA summary)
- K034039: Sis Plastic Surgery Matrix, Cook Biotech, Inc. (2004) Summary page 4.
- K033671: Gore Bioabsorbable Mesh, W. L. Gore & Associates, Inc. (2003) Summary page 4.
- K132025: Meso Bilayer Surgical Mesh, Kensey Nash Corporation Dba Dsm Biomedical (2013) Summary page 4.

## Most influential descendants
- K232602: 3DMatrix Surgical Mesh (2024), 1 descendant of its own
- K173333: GORE ENFORM Biomaterial (2018), 1 descendant of its own
- K243302: 3DMatrix DynaFlex (DynaFlex) (2025), 0 descendants of its own
- K222919: GORE® ENFORM Biomaterial (2022), 0 descendants of its own
- K191773: GORE BIO-A Tissue Reinforcement (2019), 0 descendants of its own

## Indications for use
GORE® BIO-A® Tissue Reinforcement is intended for use in the reinforcement of soft tissue. This includes use in patients requiring soft tissue reinforcement in plastic and reconstructive surgery. Examples of applications where GORE® BIO-A® Tissue Reinforcement may be used include: -Hernia repair as suture line reinforcement -Muscle flap reinforcement -General tissue reconstructions

Source page: https://510kreport.com/device/K163217
Methodology: https://510kreport.com/methodology